Jeremie Calais, MD, on 177Lu-PSMA therapy neoadjuvant to SBRT in omHSPC

Data from the phase 2 LUNAR trial (NCT05496959) showed that adding 2 cycles of 177lutetium-PSMA prior to stereotactic ablative radiotherapy (SBRT) significantly prolonged progression-free survival (PFS) in patients with oligometastatic hormone-sensitive prostate cancer (omHSPC).¹

The data were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany by Jeremie Calais, MD, PhD, of the University of California, Los Angeles. At the meeting, Calais spoke with Urology Times® about the key findings from the study.

In total, the study enrolled 92 patients who were randomly assigned 1:1 to receive 177Lu-PSMA plus SBRT (n = 45) or to SBRT alone (n = 47). The median prostate-specific antigen level was 1.1 ng/mL (IQR, 0.5 to 3.1).

At a median follow-up of 22 months, PFS was 17.6 months (95% CI, 15 to not reached) in the 177Lu-PSMA + SBRT arm vs 7.4 months (95% CI, 6.0 to 13.5) in the SBRT alone arm, which did reach statistical significance (HR, 0.37; 95% CI, 0.22 to 0.61; P < .0001). According to the authors, 98% of progression events were due to new lesions.

The only grade 3 adverse event was lymphopenia, which was reported in 3 patients (6.7%) in the 177Lu-PSMA plus SBRT arm and 2 patients (4.8%) in the SBRT alone arm. Calais noted that the safety profile for the combination therapy was favorable.

DISCLOSURES: Calais noted financial/advisory board disclosures with Astellas, Blue Earth Diagnostics, Curium, Fibrogen, GE Healthcare, Novartis, Nucleus Radiopharma, Radiomedix, Telix, Lantheus, POINT Biopharma, Janssen, Fusion Pharma, and Oncidium Foundation

REFERENCE

1. Calais J, Valle L, Wilhalme H, et al. Prospective randomized phase II trial of 177Lutetium-PSMA therapy neoadjuvant to stereotactic ablative radiotherapy for recurrent oligo-metastatic hormone-sensitive prostate cancer (LUNAR NCT05496959). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA90